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COVA4231, a potent CD3/CD33 bispecific FynomAb with IgG-like pharmacokinetics for the treatment of acute myeloid leukemia.
Klupsch K, Baeriswyl V, Scholz R, Dannenberg J, Santimaria R, Senn D, Kage E, Zumsteg A, Attinger-Toller I, von der Bey U, König-Friedrich S, Dupuy F, Lembke W, Albani C, Wendelspiess S, Dinkel L, Saro D, Hepler RW, Laszlo GS, Gudgeon CJ, Bertschinger J, Brack S, Walter RB. Klupsch K, et al. Among authors: lembke w. Leukemia. 2019 Mar;33(3):805-808. doi: 10.1038/s41375-018-0249-z. Epub 2018 Sep 11. Leukemia. 2019. PMID: 30206306 No abstract available.
Discovery and characterization of COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases.
Silacci M, Lembke W, Woods R, Attinger-Toller I, Baenziger-Tobler N, Batey S, Santimaria R, von der Bey U, Koenig-Friedrich S, Zha W, Schlereth B, Locher M, Bertschinger J, Grabulovski D. Silacci M, et al. Among authors: lembke w. MAbs. 2016;8(1):141-9. doi: 10.1080/19420862.2015.1093266. Epub 2015 Sep 22. MAbs. 2016. PMID: 26390837 Free PMC article. Clinical Trial.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M. Braun M, et al. Among authors: lembke w. Mol Ther Methods Clin Dev. 2024 Feb 20;32(1):101217. doi: 10.1016/j.omtm.2024.101217. eCollection 2024 Mar 14. Mol Ther Methods Clin Dev. 2024. PMID: 38496304 Free PMC article. Review.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: lembke w. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V. Yang TY, et al. Among authors: lembke w. Mol Ther Methods Clin Dev. 2022 Aug 2;26:471-494. doi: 10.1016/j.omtm.2022.07.018. eCollection 2022 Sep 8. Mol Ther Methods Clin Dev. 2022. PMID: 36092368 Free PMC article. Review.
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L. Loo L, et al. Among authors: lembke w. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991 Free article.